11Ga Cannula; Matched Bevel Tip Stylet VPT11BRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000311841), received between Dec 7, 2021 and Dec 7, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Align” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 7, 2021Failure to Align; Material Split, Cut or Torn; Failure to Align; Material Split, Cut or Torn

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BILATERAL SACRO PLASTY. IT WAS REPORTED THAT THE BEVEL TIP DID NOT ALIGN WITH TROCAR SO IT SPLIT BY THE BONE (IT LOOKED LIKE TWO SHARP POINTS WITH AN OPENING IN THE MIDDLE) AND THE ONLY WAY IT LINED UP AND AS FLUSH WAS IF IT WASN'T SCREWED INTO THE CANNULA. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12946917 ↗